Bavarian Nordic A/S announced today the initiation of a pivotal Phase 3 trial of the freeze-dried formulation of MVA-BN® smallpox vaccine in 1,110 healthy, vaccinia-naïve subjects.

Image/CDC/ John Noble, Jr., M.D.

The randomized, double-blind, multicenter trial will evaluate the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN®smallpox vaccine, similar to the prior completed Phase 3 study for the liquid-frozen MVA-BN formulation.

The Biologics License Application (BLA) for the liquid frozen formulation of MVA-BN is currently under review at the FDA, with anticipated completion and licensure in the second half of 2019. Upon completion of the current study, expectedly in 2021, the Company intends to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN. The requirement for only one Phase 3 study of the freeze-dried formulation was confirmed at an End-of-Phase 2 meeting with the regulatory authorities, following a prior Phase 2 study showing bioequivalence between the freeze-dried and liquid-frozen formulations of MVA-BN.

Based on the successful completion of the study and subsequent regulatory process, the Company anticipates approval of the freeze-dried vaccine in 2022.

“We are excited to initiate this final study which, along with the anticipated approval of the liquid-frozen MVA-BN smallpox vaccine and the completion of our new fill and finish facility later this year, will reinforce our position as the global leader in smallpox vaccines, and also enable us to expand our market opportunities in the U.S. and the rest of the world,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

The Phase 3 study and regulatory activities towards licensure are funded through an option valued at USD 37 million, which was exercised in November 2017 as part of the ongoing USD 539 million contract with the Biomedical Advanced Research and Development Authority (BARDA) for development and supply of freeze-dried MVA-BN to the U.S. Strategic National Stockpile.

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